BEUDAMED
    FDA Recall Terminated

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    Recall: Z-2241-2014 · Initiated May 9, 2014

    Recall

    Recall Number
    Z-2241-2014
    Event Number
    68527
    Firm
    Omnilife Science Inc.
    FEI Number
    3008342029
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    May 9, 2014
    Posted
    August 15, 2014
    Terminated
    August 19, 2014
    Address
    50 Oconnell Way, Ste 10, East Taunton, MA, 02718-1394

    Description

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    Reason

    Staining on hip implant.

    Action

    All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.

    Distribution

    US: CA, OK, VA, FL, MA, NY, TX

    Quantity

    13 devices